Therapeutic Hypothermia for Severe Traumatic Brain Injury in Japan
Therapeutic Strategy for Severe Head Trauma Patients With Mild Hypothermia and Estimation of Medical Expenses in Japan
3 other identifiers
interventional
150
1 country
43
Brief Summary
The purpose of this trial is to determine if mild hypothermia therapy, for severe head trauma patients, improves neurological outcome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2002
Longer than P75 for phase_3
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2002
CompletedFirst Submitted
Initial submission to the registry
August 23, 2005
CompletedFirst Posted
Study publicly available on registry
August 24, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedMay 11, 2012
May 1, 2012
5.8 years
August 23, 2005
May 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Neurological outcome
Glasgow outcome score and neuropsychological performance at 6 months after injury.
six months after the onset
Total medical expenses
Total medical expenses would be compared.
whole duration of treatment
Secondary Outcomes (2)
Physiological data
each day during the treatment
Laboratory data
each day during the treatment
Interventions
Keeping 32 - 34 degree celsius of core temperature at least for 72 hours.
Eligibility Criteria
You may qualify if:
- Traumatic brain injury; Glasgow coma score 4-8 (motor 1-5).
- Hypothermia or anti-hyperthermia must be induced within 6 hours after injury.
You may not qualify if:
- Systolic blood pressure \< 90mmHg (after resuscitation)
- Thrombocytopenia (platelets \[Plt\] \< 50,000/mm3)
- Pregnancy
- Preexisting medical conditions of severe hepatic dysfunction, heart failure or any other severe organ failure
- Deep drunkenness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (43)
National Hospital Organization Nagoya Medical Center
Nagoya, Aichi-ken, 4600001, Japan
Nagoya University Hospital
Nagoya, Aichi-ken, 4668560, Japan
Fujita Health University Hospital
Toyoake, Aichi-ken, 4701192, Japan
Chiba University Hospital
Chiba, Chiba, 2608677, Japan
Chiba Emergency Medical Center
Chiba, Chiba, 2610012, Japan
Ehime University Hospital
Tōon, Ehime, 7910295, Japan
Ohta Nishinouchi Hospital
kooriyama, Fukushima, 9638558, Japan
Gifu University Hospital
Gifu, Gifu, 5011194, Japan
Sapporo Medical University
Sapporo, Hokkaido, 0608543, Japan
The Hospital of Hyogo College of Medicine
Nishinomiya, Hyōgo, 6638501, Japan
Kanazawa University
Kanazawa, Ishikawa-ken, 9208640, Japan
Iwate Medical University
Morioka, Iwate, 0208505, Japan
Kagawa University Hospital
Kida, Kagawa-ken, 7610793, Japan
St. Marianna University, School of Medicine
Kawasaki, Kanagawa, 2168511, Japan
Kitasato University
Sagamihara, Kanagawa, 2288555, Japan
Yokohama City Seibu Hospital
Yokohama, Kanagawa, 2410811, Japan
Aizawa Hospital
Matsumoto, Nagano, 3908510, Japan
Shinshu University Hospital
Matsumoto, Nagano, 3908621, Japan
Nara Medical University
Kashihara, Nara, 6348522, Japan
Oita University Faculty of Medicine
Ōita, Oita Prefecture, 8795593, Japan
Kawasaki Medical University
Kurashiki, Okayama-ken, 7010192, Japan
National Hospital Organization Osaka National Hospital
Cyuo, Osaka, 5400006, Japan
Kansai Medical University
Moriguchi, Osaka, 5708507, Japan
Osaka Mishima Emergency Medical Center
Takatsuki, Osaka, 5691124, Japan
Saga Prefectural Hospital Kouseikan
Saga, Saga-ken, 8408571, Japan
Saitama Medical Center
Kawagoe, Saitama, 3508550, Japan
Shiga University of Medical Science
Ōtsu, Shiga, 5202192, Japan
Saiseikai Utsunomiya Hospital
Utsunomiya, Tochigi, 3210974, Japan
Tokushima University Hospital
Kuramoto, Tokushima, 7708503, Japan
Nippon Medical School
Bunkyo, Tokyo, 1138603, Japan
The University of Tokyo Hospital
Bunkyo, Tokyo, 1138655, Japan
Tokyo Medical University Hachioji Medical Center
Hachiōji, Tokyo, 1930998, Japan
National Hospital Organization Tokyo Medical Center
Meguro City, Tokyo, 1528902, Japan
Kyorin University Hospital
Mitaka, Tokyo, 1818611, Japan
Musashino Red Cross Hospital
Musashino, Tokyo, 1808610, Japan
Toho University Omori Medical Center
Ōta-ku, Tokyo, 1438541, Japan
Showa University Hospital
Shinagawa, Tokyo, 1428666, Japan
Tokyo Medical University
Shinjuku, Tokyo, 1600023, Japan
Teikyo University Hospital
tabashi City, Tokyo, 1738606, Japan
Nihon University Itabashi Hospital
tabashi City, Tokyo, 1738610, Japan
Tama Nagayama Hospital, Nippon Medical School
Tama, Tokyo, 2068512, Japan
Yamagata University Hospital
Yamagata, Yamagata, 9909585, Japan
Advanced Medical Emergency and Critical Care Center, Yamaguchi University Hospital
Ube, Yamaguchi, 7558505, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tsuyoshi Maekawa, MD, PhD
Yamaguchi University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Honorary Professor
Study Record Dates
First Submitted
August 23, 2005
First Posted
August 24, 2005
Study Start
December 1, 2002
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
May 11, 2012
Record last verified: 2012-05